Carvedilol 25 mg Tablets Recalled Due to Foreign Medication Contamination
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving contamination of a cardiac medication with a different prescription drug (Paroxetine). Although no illnesses or injuries have been reported, the presence of an unapproved medication in a prescription product represents a significant risk of harm, as the unintended drug could cause adverse effects or drug interactions in patients taking Carvedilol.
Plain-English summary
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets, lot B1273286-071521 (expiration 07/31/2022), because a 500-count source bottle contained two Paroxetine tablets (40 mg). These foreign tablets were inadvertently included when the product was repackaged into 180-count bottles (NDC 70518-1826-01), with the source medication originally manufactured by Zydus Pharm (NDC 68382-0095-05).
The recalled product was distributed to two medical facilities in Virginia and Florida. Four units were affected by this recall. Patients or healthcare providers who dispensed or received this product should verify the contents of affected bottles and ensure no Paroxetine tablets are present.
Consumers or healthcare professionals who have this product should contact their pharmacy or healthcare provider immediately.
The recalled product
- Product
- Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # B1273286-071521
- Exp 07/31/2022
Distribution
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